Events

Safety Alert for Certitude Delivery Systems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Edwards LifeSciences.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-01-12
  • Event Date Posted
    2018-01-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180112.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: edwards lifesciences certitude delivery systems the united states food and drug administration (fda) has posted a safety alert to the public and healthcare professionals regarding certitude delivery systems, manufactured by edwards lifesciences. the certitude delivery system is used for delivery of the edwards sapien 3 transcatheter heart valve, typically used during a transcatheter aortic valve replacement. the affected devices are identified as the following:- model/item numbers: 9600ct20a, 9600ct23a, 9600ct26a, 9600ct29a, 9600sds20a, 9600sds23a, 9600sds26a, 9600sds29a. lot numbers: select lot numbers between 60677270 and 60990824. manufacturing dates: 22 november 2016 to 10 july 2017. distribution dates: 9 january 2017 to 17 july 2017. the manufacturer is recalling its certitude delivery system due to a molding overflow defect in the button valve within the loader. according to the manufacturer, the overflow material could detach during placement of the delivery system and potentially embolize into the patient. such an embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. in dire situations, severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result. the manufacturer sent a "recall notification letter" to inform affected users of the device's risks and directed them to check all inventory for the affected products. product recall is on-going for details, please refer to the fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm592086.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 january 2018.

Device

Certitude Delivery Systems

Manufacturer

Edwards LifeSciences